GSK – More Good News for GSK: Diabetes Drug Restrictions Lifted

by Christopher Freeburn | November 26, 2013 11:50 am

[1]Regulators are loosening limits on a diabetes drug[2] from GlaxoSmithKline (GSK[3]).

In 2010, the U.S. Food and Drug Administration (FDA) imposed strict restrictions on the use of Avandia, which had been one of the top-selling diabetes drugs worldwide, after researchers raised safety concerns. The restrictions, which included requiring patients to join a special registry to get the drug, caused its sales to drop sharply, the Associated Press notes.

The FDA now says that additional analysis of existing research indicates that patients taking Avandia do not show a higher risk of suffering heart attacks compared to those using other diabetes treatments. The FDA restrictions were imposed after the agency was pushed by activists and lawmakers.

One critic said the FDA was trying to “save face” by relaxing the restrictions and insisted that data supports higher heart attack risks associated with Avandia use.

Earlier this week, GSK received a vote of confidence from government regulators when its bird flu vaccine was cleared for stockpiling in the event of a pandemic[4]. The vaccine will not be made available commercially.

Despite the news, shares of GSK fell about 1% in Tuesday morning trading.